Trial Outcomes & Findings for Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada (NCT NCT03784898)
NCT ID: NCT03784898
Last Updated: 2022-03-28
Results Overview
Each participant provided a maximum total of 69 milliliter of whole blood sample. Samples were collected in the following order: 1. Deoxyribonucleic acid (DNA) Paired box (PAX)gene tubes (2 tubes), 2. Ribonucleic acid (RNA) PAXgene tubes (2 tubes), 3. Ethylenediaminetetraacetic acid (EDTA) tubes for peripheral blood mononuclear cells (PBMCs) (5 tubes), 4. Serum Separator tube (SST) (1 tube), and 5. Dipotassium Ethylenediaminetetraacetic acid (K2EDTA) tube (1 tube); where DNA PAXgene tubes were used for DNA preparation, RNA PAXgene tubes for RNA preparation, EDTA for PBMC isolation, SST tubes for serum preparation and K2EDTA for plasma preparation. DNA was extracted from peripheral blood for future analysis.
COMPLETED
PHASE4
13 participants
Baseline (Day 1)
2022-03-28
Participant Flow
The study was conducted at a single site in the United States. A total of 14 participants were screened between 8 February 2019 to 11 December 2019, of which,1 participant was screen failure. Screen failures was mainly due to inclusion criteria not met.
A total of 13 participants were enrolled in the study.
Participant milestones
| Measure |
Participants Diagnosed With ITP
Participants with Relapsing Forms of Multiple Sclerosis (RMS) who developed Immune thrombocytopenic purpura (ITP) after Lemtrada treatment were included in this study and provided blood samples for future genetic testing and biomarker analysis.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada
Baseline characteristics by cohort
| Measure |
Participants Diagnosed With ITP
n=13 Participants
Participants with RMS who developed ITP after Lemtrada treatment were included in this study and provided blood samples for future genetic testing and biomarker analysis.
|
|---|---|
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Age, Continuous
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48.2 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1)Population: Analysis was performed on all enrolled population.
Each participant provided a maximum total of 69 milliliter of whole blood sample. Samples were collected in the following order: 1. Deoxyribonucleic acid (DNA) Paired box (PAX)gene tubes (2 tubes), 2. Ribonucleic acid (RNA) PAXgene tubes (2 tubes), 3. Ethylenediaminetetraacetic acid (EDTA) tubes for peripheral blood mononuclear cells (PBMCs) (5 tubes), 4. Serum Separator tube (SST) (1 tube), and 5. Dipotassium Ethylenediaminetetraacetic acid (K2EDTA) tube (1 tube); where DNA PAXgene tubes were used for DNA preparation, RNA PAXgene tubes for RNA preparation, EDTA for PBMC isolation, SST tubes for serum preparation and K2EDTA for plasma preparation. DNA was extracted from peripheral blood for future analysis.
Outcome measures
| Measure |
Participants Diagnosed With ITP
n=13 Participants
Participants with RMS who developed ITP after Lemtrada treatment were included in this study and provided blood samples for future genetic testing and biomarker analysis.
|
|---|---|
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Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
DNA PAXgene (tube 2)
|
12 Participants
|
|
Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
EDTA for PBMCs (tube 3)
|
13 Participants
|
|
Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
EDTA for PBMCs (tube 5)
|
5 Participants
|
|
Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
DNA PAXgene (tube 1)
|
12 Participants
|
|
Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
RNA PAXgene (tube 1)
|
12 Participants
|
|
Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
RNA PAXgene (tube 2)
|
12 Participants
|
|
Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
EDTA for PBMCs (tube 1)
|
13 Participants
|
|
Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
EDTA for PBMCs (tube 2)
|
13 Participants
|
|
Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
EDTA for PBMCs (tube 4)
|
13 Participants
|
|
Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
SST tube
|
12 Participants
|
|
Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
K2EDTA tube
|
12 Participants
|
Adverse Events
Participants Diagnosed With ITP
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER